Quality Engineer

US-MN-Eagan
2 months ago
Job ID
2017-2718
# Positions
1
Experience (Years)
5
Category
Engineering
Company
Braemar Biotelemetry Technology

Overview

The Quality Engineer will be responsible for ensuring compliant and effective introductions of new product designs and in driving continuous product quality improvement in the field. 

The Quality Engineer will work cross-functionally with Design Engineering and Manufacturing to ensure robust device designs are validated, qualified and launched. In addition to new development, the responsibilities will include working on cross-functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and planned projects.

He/she will analyze defects stemming from the design and / or manufacturing phase and leveraging the data to improve quality performance. The incumbent will work closely with Design Engineering to make sure processes comply with FDA and ISO regulations and requirements as well as ensure quality of our products.

Responsibilities

  • Ensure compliant and effective execution of design control and production processes
  • Drive continuous improvement actions focused on product quality
  • Provide Subject Matter Expertise (SME) and mentoring in all Quality System Elements, with particular strength in Design and Production Process controls
  • Participate in audits and inspections as requested
  • Analyze product quality data to identify trends or issues requiring action or CAPA activity
  • Assist in establishing production sampling/inspection plans and quality measures
  • Provide leadership in quality decisions related to product release and suppler quality
  • Lead large scope global projects as assigned

Qualifications

  • Bachelor’s degree in Engineering or related scientific / technical field; or equivalent combination of education and experience
  • Five (5) or more years related experience in a Quality Engineering capacity preferably within a FDA medical device regulated industry; technical QA experience in a regulated industry such medical device manufacturing experience preferred
  • Strong knowledge and understanding of US Quality System Regulations 21 CFR Part 820, ISO 14971 and ISO13485 regulations
  • Deep knowledge of data analysis and statistical techniques
  • Above average knowledge of CAPA and other change management techniques
  • Proven experience in driving compliance and quality improvement in design and manufacturing
  • Proven experience leading large scope improvement projects
  • Strong knowledge of failure investigation principles
  • Proven analytical and problem resolution skills
  • Ability to understand, interpret, and explain technical issues with medical devices
  • Excellent written and oral communication skills
  • Strong attention to detail with excellent accuracy

Company

Braemar Biotelemetry Technology

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